Title : Efficacy and safety of Imeglimin IR 1000 mg in inadequately controlled type 2 diabetes mellitus: A Phase III, randomized, double-blind study in India
Abstract:
Imeglimin is a novel oral antidiabetic agent developed for the treatment of type 2 diabetes mellitus (T2DM). Belonging to the new class of glimins, it targets mitochondrial bioenergetics to improve glucose homeostasis. Imeglimin exhibits a unique dual mechanism of action, enhancing insulin sensitivity in peripheral tissues and improving insulin secretion from pancreatic β-cells. Additionally, it reduces hepatic gluconeogenesis and oxidative stress. Clinical trials have demonstrated its efficacy in lowering HbA1c levels, with a favorable safety and tolerability profile, including a low risk of hypoglycemia. Imeglimin offers a promising therapeutic option for patients with T2DM, either as monotherapy or in combination with other antidiabetic agents.
Objectives:
- To evaluate the efficacy, safety, and tolerability of imeglimin hydrochloride 1000 mg tablets in participants with T2DM inadequately controlled with diet and exercise.
Results:
- A phase III, randomized, double-blind, placebo-controlled, comparative, parallel-group, multicentric clinical study conducted in India between February 2022 and June 2022, lasting for 16 weeks (CTRI/2022/02/040348).
- The study involved participants aged 18-65 years with T2DM who were treatment-naive and had inadequately controlled glycemic levels (HbA1c levels of >7.0% to ≤8.5%) despite at least three months of diet and exercise therapy before screening.
- Participants were randomized to receive either imeglimin hydrochloride tablets 1000 mg (test drug) or placebo in a 2:1 ratio.
- Demographics data, mean change in HbA1c, fasting plasma glucose (FPG) and 2-hour postprandial glucose (PPG) from baseline to week 16 were evaluated.
